Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients

This is a prospective, single center, open-label, safety and tolerability study on the use
of Myfortic after liver transplantation. Adult liver transplant patients who are
experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
attributable to CellCept are eligible to enter the study. CellCept will be discontinued and
replaced with Myfortic. The duration of the study will be 3 months, and during this time, we
will assess the incidence and severity of GI adverse events, the incidence and severity of
bone marrow suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection
or disease in patients receiving Myfortic.

Inclusion Criteria:

- ALL patients will be adult liver transplant recipients, males or females, 18-80 years
of age

- Patients currently receiving tacrolimus or cyclosporine with or without
corticosteroids as part of their immunosuppressive regimen

- Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea,
vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)

- Patients must be more than 30 days post-transplant to be eligible

- Females of childbearing potential must have a negative serum pregnancy test prior to
the inclusion period

Exclusion Criteria:

- Multi-organ transplant patients

- HIV positive patients.

- Living-related liver transplant recipients

- Pregnant patients

- Patients with a history of extra-hepatic malignancy within the last five years,
except excised squamous or basal cell carcinoma of the skin

- Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of
<1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to
enrollment

- Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection
or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis,
inflammatory bowel disease)

- Presence of clinically significant infection requiring continued therapy or
uncontrolled diabetes mellitus

- Evidence of drug and/or alcohol abuse

- Decisionally impaired subjects who are not medically or mentally capable of providing
consent themselves